Clinical trials: Shoulder Fractures
Osteoarthritis, Rheumatoid Arthritis
A Clinical Investigation of the Copeland™ Humeral Resurfacing Head
The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™ Humeral Resurfacing Head Prosthesis for outcome and durability.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis, Humeral Fractures
- Trial name
- NCT00698750
- Volunteers
- 34 people
- Sponsor
- Biomet Orthopedics, LLC
Osteo Arthritis Shoulders, Osteonecrosis
Exactech Shoulder Post Market Clinical Follow-up Study
The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time.
- Conditions
- Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy
- Trial name
- NCT05603728
- Where
- 40 sites in United States, Canada and 4 more
- Volunteers
- 20,000 people
- Sponsor
- Exactech
Bankart Lesions, SLAP Lesion
PMCF Study on the Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and JuggerLoc™ in the Shoulder
The study is a multicenter, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect data confirming safety, performance and clinical benefits of the…
- Conditions
- Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction
- Trial name
- NCT05584553
- Testing
- ToggleLoc 2.9 mm soft tissue device, JuggerLoc soft tissue device
- Where
- 3 sites in United States, Spain
- Volunteers
- 214 people
- Sponsor
- Zimmer Biomet
Proximal Humerus Fracture, Posttraumatic Arthrosis After Humeral Head Fracture
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Conditions
- Proximal Humerus Fracture, Posttraumatic Arthrosis After Humeral Head Fracture, Posttraumatic Necrosis of the Humeral Head
- Trial name
- NCT05351112
- Where
- Spain
- Volunteers
- 78 people
- Sponsor
- Zimmer Biomet
Traumatic Arthropathy of Shoulder, Fracture Humerus
Perform® Humeral System - Fracture Study (PFX)
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available…
- Conditions
- Traumatic Arthropathy of Shoulder, Fracture Humerus, Traumatic Arthritis, Revision of Other Devices if Sufficient Bone Stock Remains
- Trial name
- PFX (NCT05773352)
- Testing
- Tornier Perform® Humeral System - Fracture
- Where
- 9 sites in United States
- Volunteers
- 118 people
- Sponsor
- Stryker Trauma and Extremities
Shoulder Arthritis, Shoulder Osteoarthritis
S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem
- Conditions
- Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis, Osteoarthritis
- Trial name
- NCT05314387
- Testing
- SMR TT Hybrid Glenoid without Cementless Finned Short Stem, SMR TT Hybrid Glenoid with Cementless Finned Short Stem
- Volunteers
- 100 people
- Sponsor
- Limacorporate S.p.a
Osteoarthritis, Rheumatoid Arthritis
Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture
- Trial name
- NCT01480453
- Testing
- Trabecular Metal Humeral Stem
- Where
- 3 sites in United States
- Volunteers
- 67 people
- Sponsor
- Zimmer Biomet
Humeral Fracture, Proximal, Glenohumeral Osteoarthritis
RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS. The included cases will be followed for 10 years after index surgery.
- Conditions
- Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear
- Trial name
- NCT07558590
- Testing
- Shoulder arthroplasty
- Where
- 22 sites in France, Monaco
- Volunteers
- 1,004 people
- Sponsor
- FX Solutions
Shoulder Fractures, Shoulder Arthritis Osteoarthritis
Zimmer Biomet Shoulder Arthroplasty PMCF Study
This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in…
- Conditions
- Shoulder Fractures, Shoulder Arthritis Osteoarthritis, Shoulder Injury, Shoulder Pain
- Trial name
- NCT06920459
- Testing
- Alliance™ Glenoid
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Arthritis, Arthritis, Degenerative
Clinical Evaluation of the TITAN™ Total Shoulder System
A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.
- Conditions
- Arthritis, Arthritis, Degenerative, Rheumatoid Arthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
- Trial name
- NCT03245320
- Testing
- Integra TITAN™ Total Shoulder Generation 1.0
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease
- Trial name
- NCT04003311
- Testing
- Comprehensive Primary Micro Stem, Comprehensive Anatomic Versa-Dial Titanium Humeral Head
- Where
- 4 sites in United States
- Volunteers
- 146 people
- Sponsor
- Zimmer Biomet
Labral Tear, Glenoid, Acetabular Labrum Tear
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors…
- Conditions
- Labral Tear, Glenoid, Acetabular Labrum Tear, Bankart Lesions, Anterior Shoulder Instability
- Trial name
- NCT03985839
- Testing
- MICRORAPTOR™ REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor, MICRORAPTOR™ Knotless PEEK Suture Anchor
- Where
- 12 sites in United States
- Volunteers
- 298 people
- Sponsor
- Smith & Nephew, Inc.
Arthroplasty, Replacement
SMR Stemless Reverse Vs SMR Reverse Shoulder System
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
- Trial name
- NCT04697004
- Testing
- Investigational Arm: SMR Stemless Reverse, Control Arm: SMR Reverse Shoulder System
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Limacorporate S.p.a
Fracture
Anatomical Shoulder™ Fracture PMCF Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.
- Trial name
- NCT02465398
- Testing
- Fracture Shoulder Arthroplasty
- Where
- 3 sites in Germany, Switzerland and 1 more
- Volunteers
- 52 people
- Sponsor
- Zimmer Biomet
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System FR
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT05926622
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Rheumatoid Arthritis, Osteoarthritis Shoulder
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis
- Trial name
- REVIVE (NCT05500066)
- Testing
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Stryker Trauma and Extremities
Shoulder Fractures, Shoulder Arthritis
Zimmer Biomet Shoulder Arthroplasty PMCF
The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty.
- Conditions
- Shoulder Fractures, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Deformity
- Trial name
- NCT04984291
- Testing
- Alliance Glenoid, Identity Stem
- Where
- 17 sites in United States, Japan and 1 more
- Volunteers
- 584 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Rheumatoid Arthritis
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture
- Trial name
- NCT01480440
- Testing
- Trabecular Metal Reverse Shoulder System
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Shoulder Disease, Shoulder Fractures
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a…
- Conditions
- Shoulder Disease, Shoulder Fractures, Shoulder Arthroplasty for Revision of Previous Treatment
- Trial name
- NCT05284357
- Testing
- Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System, Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System, Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System
- Where
- 20 sites in France, Monaco
- Volunteers
- 416 people
- Sponsor
- FX Solutions
Glenohumeral Osteoarthritis, Proximal Humerus Fracture
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively.
- Conditions
- Glenohumeral Osteoarthritis, Proximal Humerus Fracture, Rotator Cuff Arthropathy, Rheumatoid Arthritis
- Trial name
- NCT07678034
- Testing
- Tipmed™ Reverse Shoulder Prosthesis System, Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 54 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.